FDA.reportPublic FDA data

Hydrel

Manufacturer
Paradigm Labs, Inc.
Effective date
2021-11-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:26:35

Label at a glance#

ProductHydrel
Active ingredientALCOHOL
Label structure11 sections

Dosage and administration

Depress sprayer lightly for stream, or depress firmly for spray. Place enough product on hands to cover. Rub hands together until dry. Supervise children under 6 years of age when using this product.

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 65% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer is used to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

On children less than 2 months of age

On open skin wounds

OTC - WHEN USING SECTION

When using this product: keep out of eyes, ears, and mouth. In case of contact with eyes, rinse thoroughly with water.

Stop using and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Depress sprayer lightly for stream, or depress firmly for spray.

Place enough product on hands to cover. Rub hands together until dry.

Supervise children under 6 years of age when using this product.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified water USP, isopropyl alcohol, glycerin, carbomer, hydrogen peroxide, triisopropylamine

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HydrelHydrel100 ml NDC 78918-901-01

3785 ml NDC 78918-901-03 Gallon labelGallon label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78918-90178918-901-01, 78918-901-03, 78918-901-02, 78918-901-04, 78918-901-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
ALOEV5VD430YW9IACT
GLYCERINPDC6A3C0OXIACT
TRIISOPROPANOLAMINEW9EN9DLM98IACT
CARBOMER 9804Q93RCW27EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d12849b5-4567-692c-e053-2a95a90ad407a9f6e8a9-3bfb-b2d7-e053-2995a90abdb52021-11-19WarningsExact identifier
spl id: d12849b5-4567-692c-e053-2a95a90ad407
spl set id: a9f6e8a9-3bfb-b2d7-e053-2995a90abdb5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.